A place for a tired old woman to try to figure things out so that the world makes a bit of sense.

Monday, July 26, 2010

Some Good News

In the past month I've followed the stories on Avandia, the GlaxoSmithKlein glucose lowering drug for Type 2 diabetics (the last one is here). The drug is effective at lowering blood glucose, but it comes with the increased risk for heart disease, heart attack, and stroke. The manufacturer knew this from the start, but kept that part of the drug information quiet until the deaths began to mount and investigators began looking into the potential link.

That shouldn't have happened. Now, an international agreement to prevent drug companies from keeping unflattering results of clinical trials secret has emerged, and that's very good news.

LURKING BENEATH some of the biggest prescription drug scandals of our time is the specter of unflattering data that was known to pharmaceutical companies and could have revealed problems sooner had it been made public. Now, an international federation of drug manufacturers, whose members include the industry’s main players, has pledged to submit most clinical trial results for publication in peer-reviewed journals, whether the outcome is positive or negative.

This step should inject transparency into the now-murky process of data disclosure. But it will work only if there is a concerted effort by companies, journals, and regulators to ensure that all trials are published, and in a timely manner. Disclosure of unflattering data doesn’t just provide a fuller picture of how useful and safe a drug might be in treating a given medical condition; it also provides some guidance to researchers studying similar drugs and similar illnesses.

There will be some obstacles to overcome in the introduction of the new protocol. The most obvious one will be to get the journals to publish the results after a careful peer review process. There are only so many medical and scientific journals on the market, and timeliness is the key to this agreement. However, if there needs to be more journals, this agreement just might call them into existence.

But the regulators at the FDA and other federal agencies will also have to do their part in the process. They will have to put aside their rubber stamps of approval and actually do their job, checking to make sure the studies say what the applications claim they say. Regulators will actually have to read the reports of the studies and they will have to make certain that the studies have been published and reviewed by their peers.

If both obstacles are erased by the diligence the new agreement mandates, there will be no more Vioxx and Avandia scandals. Patients and their doctors will be able to make informed choices in treatment options. We'll all be better off.

This time it looks like the pharmaceutical companies have gotten it right.